CVCs Versus Midline Catheters

Not Applicable

Not yet recruiting

• Conditions: Central Venous Catheter; Midline Catheter; Complication of Catheter

• Registration Number: NCT06884176
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

The goal of this clinical trial is to learn if midline catheters can reduce adverse patient outcomes in adult patients requiring a single vasopressor. The main questions the study aims to answer are:

* Do midline catheters reduce the rates of catheter-related bloodstream infections as compared to central venous catheters?

* Do midline catheters reduce the rates of deep venous thrombosis as compared to central venous catheters? Researchers will compare midline catheters to central venous catheters to see if there is a reduction in these events.

Participants will be randomized to the midline catheter group or the central venous catheter group. The catheters will be part of standard of care for vasopressor therapy. The participants will be followed for 30 days.

Detailed Description

Within the United States, around 5 million central venous catheters (CVCs) and 150 million peripheral catheters are inserted annually. A 2015 surveillance survey across 10 U.S. states revealed that 4% of hospitalized patients had 1 or more healthcare-associated infections, with 25.6% reported as device-associated infections. Device-associated infections included catheter-related bloodstream infection (CRBSI), catheter-associated urinary tract infections, and ventilator-associated pneumonia. In addition to increased rates of CRBSI, CVCs are associated with upper extremity deep venous thrombosis (DVT). Peripherally inserted central catheters (PICCs) have previously been proposed as an alternative to CVCs to avoid these complications. However, due to the increasing lumen diameter of PICCs, increased rates of catheter-related thrombosis as compared to CVCs have been reported. In contrast to PICCs where the catheter tip ends at the cavo-atrial junction near the right atrium, midline catheters are peripheral vascular devices inserted into the upper extremity veins that terminate at or below the axillary vein. As midlines terminate prior to the large vasculature of the chest, studies have demonstrated lower rates of CRBSI or DVTs as compared to the reported incidence of such complications with PICCs or CVCs. To date, there have been no large-scale randomized control trials comparing CVC and midline complication rates, including thrombosis, CRBSI, central-line associated readmission, and overall patient mortality.

The authors plan to conduct a parallel, 2-group, open-label randomized control trial at a single urban academic center. A convenience sample of adult patients will be obtained over the course of 1 year. Patients with single vasopressor requirements will be subject to enrollment. Patients will be enrolled in the study by clinicians participating in their care who are involved in the placement of the catheter (midline or CVC). Informed consent will take place in the emergency department (ED) prior to the catheter placement. Clinicians will ask patients who are being treated whether they are interested in the study. Study team members will then approach interested patients to obtain consent for the research.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Study Start: 2025-06-01
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients over 18 years of age being treated in the Emergency Department at Jacobi Medical Center

  • Have an upper extremity (left or right arm) that can accept a midline catheter
  • Able to provide consent (patient or health care proxy)
  • Clinical team believes the patient will require inpatient admission at the time of needing intravenous access
  • Requires a central line or midline catheter as an expected requirement of care

• Patients requiring a single vasopressor due to hypotension

Exclusion Criteria

• Patients in cardiac arrest (prior to achieving ROSC)
• Patients with infection or burns at both upper extremities
• Patient expected to be discharged from the hospital within 24 hours
• Prisoner
• Pregnancy
• Children less than 18 years of age
• The patient is known or is suspected to be allergic to materials contained in the device
• Patients known to have bacteremia
• Patients with existing central venous catheter
• Patients without the ability to consent (or no health care proxy to consent)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of catheter related bloodstream infections (CRBSI) within 28 days of placement	Up to 28 days from placement of catheter	The number of CRBSIs will be determined by clinical signs of infection (i.e., fever, chills, leukocytosis or hypotension) and at least one positive blood culture within 28 days of placement of catheter. The total number of CRBSIs will be recorded per study arm.

Secondary Outcome Measures

Name	Time	Method
Number of catheter failures	Up to 28 days from catheter placement	Any mechanical failures (accidental withdrawal or dislodgement, breakage, occlusion) will be documented. The total number of mechanical failures will be recorded, 1 or more per patient, by study arm. The type of mechanical failures will not be itemized.
Total number of replacement catheters	Up to 28 days	The total number of replacement IV catheters required will be documented. This will be assessed based on each study arm (midline and central line).
Total number of upper extremity deep venous thrombosis events	From catheter insertion up to hospital discharge, up to 28 days from catheter insertion.	This is defined as symptomatic or asymptomatic DVT, verified by ultrasound or computed tomography. The total number of upper extremity DVT events will be recorded by study arm.
Number of catheter leakage events	Up to 28 days from catheter placement	Catheter leakage events is defined as leakage of blood or fluids from the puncture site. The total number of catheter leakage events will be recorded by study arm.
Number of catheter infiltration events	Up to 28 days from catheter insertion	Catheter infiltration events is defined as infiltration/swelling or pain around the insertion site with medication or fluid administration. The total number of catheter infiltration events will be recorded by study arm

Trial Locations

Locations (1)

Jacobi Medical Center; 🇺🇸 Bronx, New York, United States